A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

NCT ID: NCT00698750

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2009-11-30

Brief Summary

The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Humeral Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Copeland™ Humeral Resurfacing Head

Copeland™ Humeral Resurfacing Head

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis
• Correction of functional deformity
• Reconstructable Rotator Cuff
• Treatment of acute fracture of the humeral head
• Traumatic arthritis

Exclusion Criteria

• Patients less than 18 years.
• Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis.
• Patients with marked bone loss apparent on roentgenogram.
• Metabolic disorders, which may impair bone formation.
• Patients who are pregnant.
• Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site.
• Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis.
• Patients who have had revision procedures where other devices or treatments have failed.
• Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc).
• Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
• Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome.
• Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
• Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth J Beres, MD

Role: STUDY_DIRECTOR

Director, Clinical Research, Biomet Orthopedics, LLC

Other Identifiers

Biomet 12381-30

Identifier Type: -

Identifier Source: org_study_id